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OpenTrials
Completed

NCT Number: NCT03633656

Iron Dosing Pilot Study Using Model Predictive Control

This is a pilot study to test the utility of an integrated approach in the management of the anemia of chronic kidney disease through the administration of both an erythropoietic stimulating agent and iron. Subjects will be studied for 6 months during which all iron dosing will be recommended using a computer based tool using model predictive control. Comparisons will be made to the 6 months prior to enrollment in to the study.

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Key information

Conditions

Renal Insufficiency, Chronic Anemia Anemia of Chronic Kidney Disease Anemia, Hypochromic Anemia, Iron Deficiency Anemia, Iron-Deficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic kidney disease
  • anemia
  • receiving intravenous iron

Exclusion criteria

  • none

Treatment and study plan

Model predictive control

Device

Computer aided dose selection for the treatment of iron deficient anemia.

Model Predictive Control of Iron Dosing

Device

Model Predictive Control of Iron Dosing

Primary outcomes

  1. Percentage of tsat values within range

    Time frame: Monthly for 6 months

    Tsat is measured as a percent saturation, desired range is 20 to 50%

Secondary outcomes

  1. Iron dose over ride by physician

    Time frame: Monthly for 6 months

    Number of recommended iron doses that the prescribing physician altered.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2018
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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